E10
Conditions
Interventions
Group 1: After positive screening 4 in-house visits are scheduled in a timeframe of 9 days.
A predefined Insulin Bolus is administered at every visit under controlled conditions to assess catheter per
Sponsors
ConvaTec B2BR&D and Business Development Unomedical a/s
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Informed consent obtained after being advised of the nature of the study - Male or female aged =18 years - Type 1 diabetes for at least 12 months according to the WHO definition - Regular use of insulin aspart or glulisine for diabetes management - C-peptide <0.3nmol/L - Treatment with continuous subcutaneous insulin infusion (CSII) for at least 6 months (an interruption of 3 months is allowed) - Body Mass Index (BMI) 20-28kg/m² - Willing and able to wear a CGM device and use the study specific insulin pump and study specific catheters for the duration of the study and undergo all study procedures - HbA1c = 86 mmol/mol - Stable body weight in the last 3 months prior to study start (change in body weight <5%)
Exclusion criteria
Exclusion criteria: - Non-insulin hypoglycemic agents - Regular use of insulin lispro for diabetes management - Diabetic ketoacidosis during the previous 12 months - Severe hypoglycemia requiring third party help, hospitalization or emergency room visit during the previous 12 months - Hypoglycemia unawareness - Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods - Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator (e.g. scar tissue) - History of bleeding disorder - Current participation in another clinical study - Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator - Smoker (> 5 cigarettes per day) - Lipodystrophy - Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months. - Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen that in the opinion of the Investigator would compromise the subject’s safety or successful participation in the study - Known adrenal gland problem, pancreatic tumour, or insulinoma - Inability of the subject to comply with all study procedures - Inability of the subject to understand the patient information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tmax(GIR), time to maximum glucose infusion rate on days 1, 4 and 7 of catheter wear-time | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints (0 to 8 hours after bolus administration using Insulin-Glucose Clamp technique) • t10% max(GIR) • t50% max(GIR) • GIRmax • AUC (= area under the cuve) 0-8h(GIR) • AUC0-0.5h(GIR), AUC0-1h(GIR), AUC0-2h(GIR), AUC0-4h(GIR), AUC0-6h(GIR) • AUC0-tmax(GIR) • AUC0-8(GIR) • Onset of action • Duration of Action Pharmacokinetic endpoints (0 to 8 hours after bolus administration --> regular blood samples) • tmax(ins = Insulin) • t10%max(ins) • t50%max(ins) • Cmax(ins) • AUC0-8(ins) • AUC0-0.5h(ins), AUC0-1h(ins), AUC0-2h(ins), AUC0-4h(ins), AUC0-6h(ins) • AUC0-tmax(ins) • AUC0-8(ins) • Onset of appearance Catheter survival • Survival time of the newly coated Lantern catheter in days • Percentage of surviving insulin infusion catheters over time Flash glucose monitoring: • Time in target (70-180mg/dL (3.9-10.0mmol/L)) • Time in hyperglycemia (>180mg/dL (>10.0mmol/L)) • Time in hypoglycemia (<70mg/dL (<3.9mmol/L)) • Glucose variability Insulin dose: • Total daily insulin dose (IU = Insulin Units) • Daily basal insulin rate (IU) • Daily bolus insulin dose (IU) Blood glucose (subject diary; blood sampling at in-house visits): • Mean daily blood glucose | — |
Countries
Austria
Contacts
Public ContactDaniela Schwarzenbacher
Clinical Research Center, Medizinische Universität Graz
Outcome results
None listed